2 years
0 Lacs
Posted:23 hours ago|
Platform:
On-site
Full Time
Designation: Sr. Executive/Asst. Manager/Deputy Manager
Location: Mumbai.
Qualification: M. Pharm
Experience: 2+ Years of relevant experience in Domestic Market
Industry: Pharmaceutical
The role involves managing regulatory processes under D&C Act, FSSAI, and FDA guidelines. Responsibilities include preparing registration dossiers, coordinating with R&D and QC for documentation, handling FDA/DCGI/FSSAI licenses and renewals, and ensuring compliance through online portals like Sugam. You’ll oversee regulatory submissions, label/artwork compliance, packaging reviews, and maintain proper documentation.
In addition, the role involves basic pharmacovigilance work like drafting PSURs, reviewing risk management plans, and ensuring product safety reporting aligns with regulatory standards.
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